The Influence of Renal Impairment on Clinical Outcomes in Venous Thromboembolism Patients Enrolled in GARFIELD-VTE
ISTH Academy. Goto S. 07/07/19; 273885; OC 24.1 Topic: DOACs
Shinya Goto
Shinya Goto
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OC 24.1

The Influence of Renal Impairment on Clinical Outcomes in Venous Thromboembolism Patients Enrolled in GARFIELD-VTE

S. Goto1, A.G.G. Turpie2, A. Zaghdoun3, J.I. Weitz4, S. Haas5, W. Ageno6, S.Z. Goldhaber7, P. Angchaisuksiri8, J. Dalsgaard Nielsen9, G. Kayani3, S. Schellong10, H. Bounameaux11, L.G. Mantovani12, P. Prandoni13, A.K. Kakkar3, on behalf of the GARFIELD-VTE Investigators
1Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, 2McMaster University, Hamilton, Canada, 3Thrombosis Research Institute, London, United Kingdom, 4McMaster University and Thrombosis and Atherosclerosis Research Institute, Ontario, Canada, 5Formerly Technical University of Munich, Munich, Germany, 6University of Insubria, Department of Medicine and Surgery, Varese, Italy, 7Harvard Medical School, Boston, United States, 8Ramathibodi Hospital, Mahidol University, Department of Medicine, Bangkok, Thailand, 9Copenhagen University Hospital, Copenhagen, Denmark, 10Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, 11University Hospital of Geneva, Faculty of Medicine, Geneva, Switzerland, 12University degli Studi di Milano Bicocca, Milan, Italy, 13Arianna Foundation on Anticoagulation, Bologna, Italy

Main Topic: Venous Thromboembolism
Category: DOACs

Background: Venous thromboembolism (VTE) patients with concomitant chronic kidney disease (CKD) represent a complex patient group, with an increased risk of thrombosis as well as serious bleeding complications. Moreover, anticoagulation is challenging because the majority of anticoagulant drugs are excreted by kidney.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month outcomes between patients with moderate-to-severe (stages 3-5) CKD and patients with normal-to-mild (stages 1-2) CKD enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 8,939 of which (normal-to-mild CKD n=6897, moderate-to-severe CKD n=2042) were eligible for analysis in this study.
Results: The distribution of VTE events was comparable between groups (moderate-to-severe CKD: 57.1% deep vein thrombosis (DVT) alone, 42.9% pulmonary embolism (PE) ± DVT; normal-to-mild: 58.9% DVT alone, 41.1% PE ± DVT). Moderate-to-severe CKD (vs. normal-to-mild CKD) was more common in females (57.0% vs. 47.0%). Moderate-to-severe CKD patients were older; mean (standard deviation) 67.4 (14.8) years vs. 56.1 (16.6) years, but BMI; mean (standard deviation) was comparable to patients with normal-to-mild CKD: 29.2 (6.9) kg/m2 vs. 28.1 (6.5) kg/m2, respectively. Chronic heart failure (6.8% vs. 2.2%), chronic immobilisation (7.1% vs. 5.3%) and a history of cancer (17.2% vs. 12.9%) were all more common in moderate-to-severe CKD patients compared to normal-to-mild CKD patients, respectively. No clinically meaningful differences were found between treatment patterns at baseline between groups (Table 1). Over 12-months follow-up, patients with moderate-to-severe CKD were at an increased risk (hazard ratio [95% confidence interval]) of all-cause mortality (1.92 [1.63-2.26]), major bleeding (1.94 [1.41-2.68]), and recurrent VTE (1.27 [1.02-1.57]) (Table 2).
Conclusions: VTE patients with moderate-to-severe CKD are at an increased risk of major adverse outcomes.


Treatment Moderate-to-severe CKD N (%) Normal-to-mild CKD N (%)
Anticoagulation therapy only 1877 (91.9) 6416 (93.0)
Parenteral therapy only 331 (17.6) 1130 (17.6)
Parenteral therapy + VKA 586 (31.2) 1658 (25.8)
VKA only 114 (6.1) 311 (4.8)
DOAC only 514 (27.4) 1956 (30.5)
Parenteral therapy + DOAC 286 (15.2) 1209 (18.8)
Unknown 46 (2.5) 152 (2.4)
Other therapy ± anticoagulation 123 (6.0) 382 (5.5)
No therapy or compression only 42 (2.1) 99 (1.4)
[Treatment at baseline (± 30 days of VTE diagnosis) in moderate-to-severe CKD patients vs normal-to-mild CKD patients enrolled in GARFIELD-VTE.]




Event Moderate-to-severe CKD (N=2,022) Normal-to-mild CKD (N=6,860) Hazard Ratio [95% CI] P-value
  n Rate per 100 person-years [95% CI] n Rate per 100 person-years [95% CI]    
All-cause mortality 228 12.7 [11.2-14.5] 413 6.6 [6.0-7.3] 1.92 [1.63-2.26] <0.0001
Major bleed 58 3.3 [2.5-4.2] 104 1.7 [1.4-2.0] 1.94 [1.41-2.68] <0.0001
Recurrent VTE 113 6.6 [5.5-7.9] 311 5.1 [4.6-5.7] 1.27 [1.02-1.57] 0.0301
Any bleeding 238 14.4 [12.7-16.3] 627 10.7 [9.9-11.5] 1.33 [1.14-1.54] 0.0002
Stroke/Transient Ischemic Attack 20 1.1 [0.7-1.7] 44 0.7 [0.5-1.0] 1.59 [0.94-2.70] 0.0858
Myocardial Infarction/Acute Coronary Syndrome 23 1.3 [0.9-1.9] 41 0.7 [0.5-0.9] 1.95 [1.17-3.26] 0.0101
[Table 2: 12-month outcomes in moderate-to-severe CKD patients and normal-to-mild CKD patients enrolled in GARFIELD-VTE.]

OC 24.1

The Influence of Renal Impairment on Clinical Outcomes in Venous Thromboembolism Patients Enrolled in GARFIELD-VTE

S. Goto1, A.G.G. Turpie2, A. Zaghdoun3, J.I. Weitz4, S. Haas5, W. Ageno6, S.Z. Goldhaber7, P. Angchaisuksiri8, J. Dalsgaard Nielsen9, G. Kayani3, S. Schellong10, H. Bounameaux11, L.G. Mantovani12, P. Prandoni13, A.K. Kakkar3, on behalf of the GARFIELD-VTE Investigators
1Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, 2McMaster University, Hamilton, Canada, 3Thrombosis Research Institute, London, United Kingdom, 4McMaster University and Thrombosis and Atherosclerosis Research Institute, Ontario, Canada, 5Formerly Technical University of Munich, Munich, Germany, 6University of Insubria, Department of Medicine and Surgery, Varese, Italy, 7Harvard Medical School, Boston, United States, 8Ramathibodi Hospital, Mahidol University, Department of Medicine, Bangkok, Thailand, 9Copenhagen University Hospital, Copenhagen, Denmark, 10Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, 11University Hospital of Geneva, Faculty of Medicine, Geneva, Switzerland, 12University degli Studi di Milano Bicocca, Milan, Italy, 13Arianna Foundation on Anticoagulation, Bologna, Italy

Main Topic: Venous Thromboembolism
Category: DOACs

Background: Venous thromboembolism (VTE) patients with concomitant chronic kidney disease (CKD) represent a complex patient group, with an increased risk of thrombosis as well as serious bleeding complications. Moreover, anticoagulation is challenging because the majority of anticoagulant drugs are excreted by kidney.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month outcomes between patients with moderate-to-severe (stages 3-5) CKD and patients with normal-to-mild (stages 1-2) CKD enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 8,939 of which (normal-to-mild CKD n=6897, moderate-to-severe CKD n=2042) were eligible for analysis in this study.
Results: The distribution of VTE events was comparable between groups (moderate-to-severe CKD: 57.1% deep vein thrombosis (DVT) alone, 42.9% pulmonary embolism (PE) ± DVT; normal-to-mild: 58.9% DVT alone, 41.1% PE ± DVT). Moderate-to-severe CKD (vs. normal-to-mild CKD) was more common in females (57.0% vs. 47.0%). Moderate-to-severe CKD patients were older; mean (standard deviation) 67.4 (14.8) years vs. 56.1 (16.6) years, but BMI; mean (standard deviation) was comparable to patients with normal-to-mild CKD: 29.2 (6.9) kg/m2 vs. 28.1 (6.5) kg/m2, respectively. Chronic heart failure (6.8% vs. 2.2%), chronic immobilisation (7.1% vs. 5.3%) and a history of cancer (17.2% vs. 12.9%) were all more common in moderate-to-severe CKD patients compared to normal-to-mild CKD patients, respectively. No clinically meaningful differences were found between treatment patterns at baseline between groups (Table 1). Over 12-months follow-up, patients with moderate-to-severe CKD were at an increased risk (hazard ratio [95% confidence interval]) of all-cause mortality (1.92 [1.63-2.26]), major bleeding (1.94 [1.41-2.68]), and recurrent VTE (1.27 [1.02-1.57]) (Table 2).
Conclusions: VTE patients with moderate-to-severe CKD are at an increased risk of major adverse outcomes.


Treatment Moderate-to-severe CKD N (%) Normal-to-mild CKD N (%)
Anticoagulation therapy only 1877 (91.9) 6416 (93.0)
Parenteral therapy only 331 (17.6) 1130 (17.6)
Parenteral therapy + VKA 586 (31.2) 1658 (25.8)
VKA only 114 (6.1) 311 (4.8)
DOAC only 514 (27.4) 1956 (30.5)
Parenteral therapy + DOAC 286 (15.2) 1209 (18.8)
Unknown 46 (2.5) 152 (2.4)
Other therapy ± anticoagulation 123 (6.0) 382 (5.5)
No therapy or compression only 42 (2.1) 99 (1.4)
[Treatment at baseline (± 30 days of VTE diagnosis) in moderate-to-severe CKD patients vs normal-to-mild CKD patients enrolled in GARFIELD-VTE.]




Event Moderate-to-severe CKD (N=2,022) Normal-to-mild CKD (N=6,860) Hazard Ratio [95% CI] P-value
  n Rate per 100 person-years [95% CI] n Rate per 100 person-years [95% CI]    
All-cause mortality 228 12.7 [11.2-14.5] 413 6.6 [6.0-7.3] 1.92 [1.63-2.26] <0.0001
Major bleed 58 3.3 [2.5-4.2] 104 1.7 [1.4-2.0] 1.94 [1.41-2.68] <0.0001
Recurrent VTE 113 6.6 [5.5-7.9] 311 5.1 [4.6-5.7] 1.27 [1.02-1.57] 0.0301
Any bleeding 238 14.4 [12.7-16.3] 627 10.7 [9.9-11.5] 1.33 [1.14-1.54] 0.0002
Stroke/Transient Ischemic Attack 20 1.1 [0.7-1.7] 44 0.7 [0.5-1.0] 1.59 [0.94-2.70] 0.0858
Myocardial Infarction/Acute Coronary Syndrome 23 1.3 [0.9-1.9] 41 0.7 [0.5-0.9] 1.95 [1.17-3.26] 0.0101
[Table 2: 12-month outcomes in moderate-to-severe CKD patients and normal-to-mild CKD patients enrolled in GARFIELD-VTE.]

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